Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety
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Job Description
Regulatory affairs professional joining the global regulatory and patient safety team on a temporary contract at Chiesi. Contributing to aligned global regulatory strategy and supporting lifecycle management across assigned regions.
Responsibilities:
- May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA.
- Contribute (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members
- Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings
- Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit
- Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines
- Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate
- Ensure regulatory submission timelines are aligned with program level and company objectives
- Contribute to content and reviews for regulated documents
- Support operational and compliance activities for assigned deliverables
- Support GMP, GCP, and GPV inspections from health authorities
- Accountable to provide updates on project and submissions status to GRT members
- Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners
Requirements:
- Experience in regulatory lifecycle management in Europe, particularly with MRP/DCP and centralized procedures.
- Fluent English
- Excellent attention to detail, including data consistency, traceability, and alignment across submission documents
- Ability to solve problems proactively and problem solving skills and the ability to work both independently and collaboratively in multidisciplinary team
- Fluent English
- Experience with FDA
- Experience with biological products
Benefits:
- Comprehensive healthcare programs
- Work-life balance initiatives
- Robust relocation support
- Flexible working arrangements
- Remote work options
- Tax assistance services for foreign colleagues
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